1. Field of the Invention
The present invention relates generally to catheter devices. More particularly, the present invention relates to urinary catheters having protective sheaths.
2. Background of the Invention
It has become relatively commonplace for the occasional, intermittent or periodic catheterization of an individual's urinary bladder to be employed, as opposed to placement and maintenance of an indwelling catheter that continuously drains urine from the bladder. Short-term or repeated catheterization is appropriate, or even required, for many persons who are in a hospital setting, a nursing home, doctor's office, rehabilitation facility, or in the home. For example, a patient is sometimes catheterized to treat such conditions as urinary retention, the inability to evacuate urine, or for the purpose of obtaining a sterile urine specimen from a patient in a doctor's office or for hospitalized patients.
The need for intermittent catheterization of an individual sometimes arises due to problems typically associated with long-term use of indwelling catheters, such as infections, urethral damage, and bladder damage. Long-term use of an indwelling catheter is also a risk factor for bladder cancer. This is often the case for persons having a neurogenic urinary condition, such as in a spinal cord injury, multiple sclerosis, stroke, trauma, or other brain injury. Conditions that interfere with the individual's ability to voluntarily void the bladder may also arise post-surgically or as a result of benign prostatic hypertrophy or diabetes. Many of the affected individuals are capable of, and would prefer to perform self-catheterization. For many, the level of risk and discomfort of repeated catheterizations carried out over the course of a day (at 3-6 hour intervals, for example) are offset by the accompanying convenience, privacy, or self-reliance that is achieved. Some of the major difficulties that arise in self-catheterization are the lack of satisfactory catheterization kits, the problem of maintaining the required level of sterility during the procedure, and the difficulty of sometimes performing the procedure under conditions of restricted space and privacy.
In assisted, or non self-catheterizations, it is common practice in hospitals to employ a catheterization tray, which typically includes a sterile drape, gloves, a conventional catheter, antiseptic solution, swabs, lubricant, forceps, underpad, and a urine collection container. Assisted catheterization is usually performed with the patient in a supine position. Maintaining a sterile field during the procedure can still be a problem, however, and the “cath tray” procedure is impractical for use with some individuals and situations today.
Many individuals with spinal cord injuries or other neurological diseases routinely perform intermittent catheterization several times a day using conventional catheters or kits and “clean technique.” Clean technique typically means that the urethral area is initially swabbed with antiseptic, and efforts are made to avoid contamination of the catheter during the procedure. The user's hands and catheter are not sterile and a sterile field is not maintained. Clean technique is used instead of sterile technique, generally, for two reasons. First, it is very difficult, if not impossible, for individuals who are performing self-catheterization to adhere strictly to sterile technique. Secondly, these individuals are required to catheterize themselves between 3 and 6 times a day, and the cost of a new sterile catheter and the accessories required to perform sterile catheterization becomes excessively expensive for some users. Sometimes an individual will reuse a “cleaned” catheter. As a result, the use of “clean technique” will many times result in contamination and subsequent infection of the urinary tract, causing significant morbidity and cost to the patient and society.
To maintain sterility many catheters are surrounded by sheaths. The user then holds the sheath while pulling the catheter through, avoiding direct contact with the catheter before and during insertion. While the user is pulling the catheter through the sheath, the sheath can tend to bunch up at the proximal end. Any excess air is then forced to the distal end. Towards the end of the insertion, the air can build up at the distal end inflating the sheath to a maximum, which makes it difficult to complete the insertion process. Completion can be particularly difficult for those with limited manual dexterity.